85 FR 54 pgs. 15799-15800 - Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Type: NOTICEVolume: 85Number: 54Pages: 15799 - 15800
Pages: 15799, 15800Docket number: [Docket No. DEA-602]
FR document: [FR Doc. 2020-05750 Filed 3-18-20; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-602]
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
ACTION:
Notice of application.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 18, 2020.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
[top] In accordance with 21 CFR 1301.33(a), this is notice that on September 23, 2019, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 registered as a bulk manufacturer of the following basic class(es), of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | II |
| Levomethorphan | 9210 | II |
| Levorphanol | 9220 | II |
| Remifentanil | 9739 | II |
| Fentanyl | 9801 | II |
The company plans to bulk manufacture API quantities of the listed controlled substances for validation purposes and FDA approval.
Dated: March 5, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-05750 Filed 3-18-20; 8:45 am]
BILLING CODE 4410-09-P